BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 19314140 · Received May 14, 2024

    Report

    Report Number
    3005094123-2024-00250
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    January 30, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121501
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT 54180UD00 PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 54180UD00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I TOTAL B-HCG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN VALUE OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. PER PRODUCT LABELING, FOR ACCURATE RESULTS, SERUM AND PLASMA SPECIMENS SHOULD BE FREE OF FIBRIN, RED BLOOD CELLS, AND OTHER PARTICULATE MATTER. INADEQUATE CENTRIFUGATION OR THE PRESENCE OF FIBRIN OR PARTICULATE MATTER IN THE SAMPLE MAY CAUSE AN ERRONEOUS RESULT. TO PREVENT CROSS CONTAMINATION, USE OF DISPOSABLE PIPETTES OR PIPETTE TIPS IS RECOMMENDED. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOTAL B-HCG REAGENT LOT 54180UD00.

    Additional Manufacturer Narrative · 0

    SECTION A - PATIENT IDENTIFIER, AGE AT TIME OF EVENT, SEX.: SID (B)(6) 42-YEAR-OLD FEMALE. SID (B)(6) 35-YEAR-OLD FEMALE. SID (B)(6) 42-YEAR-OLD FEMALE. SID (B)(6) 38-YEAR-OLD FEMALE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ALINITY I TOTAL B-HCG, LIST NUMBER 07P51-20, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL -HCG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR FOUR FEMALE PATIENTS. THE SAMPLES WERE REPEATED AND THE RESULTS WERE NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: PATIENT #2: 42-YEAR-OLD FEMALE (DIAGNOSIS: IN VITRO FERTILIZATION) , (B)(6) 2024 SID (B)(6) INITIAL RESULT = 507 MIU/ML (POSITIVE), REPEAT RESULTS = 1.2 MIU/ML (NEGATIVE) AND 1.2 MIU/ML (NEGATIVE). TIMELINE AND RESULTS ON PATIENT#2: (B)(6)2023 B-HCG RESULT = 1.5 MIU/ML, (B)(6)2023 IN VITRO FERTILIZATION, (B)(6)2023 B-HCG RESULT = 93.8 MIU/ML, (B)(6)2023 B-HCG RESULT = 142.81 MIU/ML, (B)(6)2023 B-HCG RESULT = 104.80 MIU/ML, (B)(6)2024 IN VITRO FERTILIZATION, (B)(6)2024 B-HCG RESULT = 1.2 MIU/ML, (B)(6)2024 B-HCG RESULT = 1.2 MIU/ML. PATIENT #6: 35-YEAR-OLD FEMALE (DIAGNOSIS: PREGNANCY, NOT (YET) CONFIRMED) (B)(6)2024 SID (B)(6) INITIAL RESULT = 2371 MIU/ML (POSITIVE) REPEAT RESULTS = 1.2 MIU/ML (NEGATIVE) AND 1.2 MIU/ML (NEGATIVE) TIMELINE AND RESULTS ON PATIENT#6: (B)(6)2023 IN VITRO FERTILIZATION (B)(6)2023 B-HCG RESULT = 1.2 MIU/ML (B)(6)2024 B-HCG RESULT = 170.41 MIU/ML (B)(6)2024 B-HCG RESULT = 784.29 MIU/ML (B)(6)2024 B-HCG RESULT = 1.2 MIU/ML (B)(6)2024 IN VITRO FERTILIZATION PATIENT #8: 42-YEAR-OLD FEMALE (DIAGNOSIS: IN VITRO FERTILIZATION) (B)(6)2024 SID (B)(6) INITIAL RESULT = 1903 MIU/ML (POSITIVE) REPEAT RESULTS = 1.2 MIU/ML (NEGATIVE) AND 1.2 MIU/ML (NEGATIVE) TIMELINE AND RESULTS ON PATIENT #8: (B)(6)2023 IN VITRO FERTILIZATION, (B)(6)2023 B-HCG RESULT = 1.2 MIU/ML, (B)(6)2024 B-HCG RESULT = 170.41 MIU/ML, (B)(6)2024 B-HCG RESULT = 784.29 MIU/ML, (B)(6)2024 B-HCG RESULT = 1.2 MIU/ML, (B)(6)2024 IN VITRO FERTILIZATION. PATIENT #10: 38-YEAR-OLD FEMALE (DIAGNOSIS: PREGNANCY, NOT (YET) CONFIRMED), (B)(6)2024 SID (B)(6) INITIAL RESULT = 498 MIU/ML (POSITIVE), REPEAT RESULT = 1.9 MIU/ML (NEGATIVE) AND 4.22 MIU/ML (NEGATIVE). TIMELINE AND RESULTS ON PATIENT #10: (B)(6)2024 B-HCG RESULT = 49.62 MIU/ML, (B)(6)2024 B-HCG RESULT = 88.09 MIU/ML, (B)(6)2024 B-HCG RESULT = 152.08 MIU/ML, (B)(6)2024 B-HCG RESULT = 175.68 MIU/ML, (B)(6)2024 B-HCG RESULT = 498.18 MIU/ML, (B)(6)2024 B-HCG RESULT = 1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL HCG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR FOUR FEMALE PATIENTS. THE SAMPLES WERE REPEATED AND THE RESULTS WERE NEGATIVE. THE FOLLOWING DATA WAS PROVIDED: PATIENT #2: 42-YEAR-OLD FEMALE (DIAGNOSIS: IN VITRO FERTILIZATION). (B)(6) 2024 SID (B)(6) INITIAL RESULT = 507 MIU/ML (POSITIVE). REPEAT RESULTS = 1.2 MIU/ML (NEGATIVE) AND 1.2 MIU/ML (NEGATIVE). TIMELINE AND RESULTS ON PATIENT#2: (B)(6) 2023 B-HCG RESULT = 1.5 MIU/ML. (B)(6) 2023 IN VITRO FERTILIZATION. (B)(6) 2023 B-HCG RESULT = 93.8 MIU/ML. (B)(6) 2023 B-HCG RESULT = 142.81 MIU/ML. (B)(6) 2023 B-HCG RESULT = 104.80 MIU/ML. (B)(6) 2024 IN VITRO FERTILIZATION. (B)(6) 2024 B-HCG RESULT = 1.2 MIU/ML. (B)(6) 2024 B-HCG RESULT = 1.2 MIU/ML. PATIENT #6: 35-YEAR-OLD FEMALE (DIAGNOSIS: PREGNANCY, NOT (YET) CONFIRMED). (B)(6) 2024 SID (B)(6) INITIAL RESULT = 2371 MIU/ML (POSITIVE). REPEAT RESULTS = 1.2 MIU/ML (NEGATIVE) AND 1.2 MIU/ML (NEGATIVE). TIMELINE AND RESULTS ON PATIENT#6: (B)(6) 2023 IN VITRO FERTILIZATION. (B)(6) 2023 B-HCG RESULT = 1.2 MIU/ML. (B)(6) 2024 B-HCG RESULT = 170.41 MIU/ML. (B)(6) 2024 B-HCG RESULT = 784.29 MIU/ML. (B)(6) 2024 B-HCG RESULT = 1.2 MIU/ML. (B)(6) 2024 IN VITRO FERTILIZATION. PATIENT #8: 42-YEAR-OLD FEMALE (DIAGNOSIS: IN VITRO FERTILIZATION). (B)(6) 2024 SID (B)(6) INITIAL RESULT = 1903 MIU/ML (POSITIVE). REPEAT RESULTS = 1.2 MIU/ML (NEGATIVE) AND 1.2 MIU/ML (NEGATIVE). TIMELINE AND RESULTS ON PATIENT #8: (B)(6) 2023 IN VITRO FERTILIZATION. (B)(6) 2023 B-HCG RESULT = 1.2 MIU/ML. (B)(6) 2024 B-HCG RESULT = 170.41 MIU/ML. (B)(6) 2024 B-HCG RESULT = 784.29 MIU/ML. (B)(6) 2024 B-HCG RESULT = 1.2 MIU/ML. (B)(6) 2024 IN VITRO FERTILIZATION. PATIENT #10: 38-YEAR-OLD FEMALE (DIAGNOSIS: PREGNANCY, NOT (YET) CONFIRMED). (B)(6) 2024 SID (B)(6) INITIAL RESULT = 498 MIU/ML (POSITIVE). REPEAT RESULT = 1.9 MIU/ML (NEGATIVE) AND 4.22 MIU/ML (NEGATIVE). TIMELINE AND RESULTS ON PATIENT #10: (B)(6) 2024 B-HCG RESULT = 49.62 MIU/ML. (B)(6) 2024 B-HCG RESULT = 88.09 MIU/ML. (B)(6) 2024 B-HCG RESULT = 152.08 MIU/ML. (B)(6) 2024 B-HCG RESULT = 175.68 MIU/ML. (B)(6) 2024 B-HCG RESULT = 498.18 MIU/ML. (B)(6) 2024 B-HCG RESULT = 1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708696 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 54180UD00 00380740121501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01,(B)(6)